Strategic Statistical Programming Leadership Role
The role of Associate Director, Statistical Programming is to provide leadership and expertise in support of clinical development and post-marketing activities for multiple therapeutic areas.
Key Responsibilities:
* Provide specific functional expertise, leadership and strategic thinking within the Biometry team.
* Responsible for ensuring overall quality of analysis and reporting deliverables for global Phase I-IV clinical trials and research publication efforts.
* Act as a lead programmer, generating/validating CDISC compliant statistical analysis database and outputs using SAS, R or other software.
* Leads the development and adaptation of new Statistical Programming tools/processes in support of drug development.
* Responsible for establishing and maintaining policies, standards and guidance for Statistical Programming operations in adherence with ICH and regulatory requirements.
* Oversees projects which relate to improving processes and quality and efficiency of clinical reporting within the Biometry team.
* Determines efficient utilization of Statistical Programming resource by leveraging both in-house staff and external vendors.
* Provides input on optimal resource utilization and capacity.
* Manages outside CROs and consultants within the programming function, as needed.
* Maintains constant and open communication to make sure timely and quality deliverables and support CRO selection processes.
* Drives the development of tools for continual assessment of CRO contributions to clinical trials.
* Provides support in the development of programmers within the Statistical Programming and Data Management teams.
* Provides Statistical Programming consultancy to colleagues, leveraging project management, technical leadership abilities and submission requirements knowledge, with a hands-on and collaborative approach.
* Contributes to the hiring and mentoring of statistical programmers within the Biometry team.
Required Skills and Qualifications:
* Expert knowledge of SAS, R or Python.
* High degree of expertise in CDISC and other industry standards, tools and regulatory requirements.
* Demonstrate a high degree of independence, technical skills, with the ability to influence the team, internal stakeholders and external vendors to achieve results with minimal to no supervision.
* Ability and experience to determine overall programming strategy for the Biometry team.
* Demonstrate strong problem solving and risk-mitigation skills.
* Is a strategic and creative thinker.
* Excellent interpersonal, verbal and written communication skills.
* Strong attention to detail and excellent organizational skills.
* Comfortable working in a dynamic, fast-paced environment.
* Bachelors' degree or higher in computer science, bioinformatics, biostatistics or related field.
* Requires a PhD with a minimum of 10 years of clinical development experience in the pharmaceutical/biotech industry or an MSc with a minimum of 12 years' experience or a BSc with a minimum of 15 years' experience.
Benefits:
* Highly competitive salary.
* Group pension scheme - Contribution rates are 5% employer and 5% employee.
* Private Medical Insurance for the employee.
* Ongoing opportunities for career development in a rapidly expanding work environment.
* Succession planning and internal promotions.
* Wellness activities.